Packing of Perianal Abscess Cavities

Perianal Abscess Clinical Trial

— PPAC2  

Official title:

The Impact of Postoperative Packing of Perianal Abscess Cavities: a Multicentre Randomised Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03315169
• Other study ID #: R04689
• Secondary ID: PB-PG-0815-20037
• Status: Completed
• Phase: N/A
• Start date: February 14, 2018
• Est. completion date: June 12, 2020

Study information

• Verified date: September 2020
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this trial is to compare internal wound packing to no packing in postoperative management following incision and drainage of perianal abscess. Participants will be randomised 1:1 to either the packing or non-packing arm.

Description:

Perianal abscess is common, affecting 18,000 patients annually in England. Management has remained largely unchanged for over 50 years, and comprises surgical incision and drainage followed by continued internal wound dressing (packing) until healed. Packing is thought to reduce the rate of recurrent abscess and perianal fistula; a known complication of perianal abscess. Perianal fistula frequently requires multiple operations to resolve. The evidence for postoperative packing is limited¹ and may expose patients to painful procedures with no clinical benefit, and at considerable increased cost².

A multi-centre observational study of outcomes after drainage of perianal abscess (PPAC²) (n=141) found packing to be painful (2-3 fold increase in Visual Analogue Score pain scores during packing) and costly (estimated cost of £280 per patient; overall cost in the United Kingdom of £5 million annually). Fistula rate was 27%.

This study is a randomised controlled trial designed to assess whether there are differences between non-packing and packing of the perianal abscess cavity in terms of the short term negative effects of packing (pain, quality of life, return to work) whilst assessing the impact on key clinical outcomes (wound healing, fistulae formation) and resource use/cost.

All participants will be required to complete pain diaries following discharge from hospital. Clinical follow up to assess healing and other key clinical outcomes will take place at 4, 8 (if not healed at 4 weeks) and 26 weeks. Further data will be collected from National Health Service Registries at 52 weeks in order to assess abscess recurrences and fistulae formation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Aged 18 or over

2. Undergoing surgical incision and drainage of a primary perianal abscess

Exclusion Criteria:

1. Suspected inflammatory bowel disease

2. Fournier's Gangrene

3. Horseshoe (bilateral) abscess

4. Fistula-in-ano

5. Multiple abscess

Related Conditions & MeSH terms

• Abscess
• Abscess Anorectal
• Abscess; Anus
• Peri Rectal Abscess
• Perianal Abscess
• Perianal Infections

Intervention

Other:
• External dressing
Application of external dressing whilst perianal abscess cavity heals.
• Packing of perianal abscess cavity
Internal packing of perianal abscess cavity - standard treatment.

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Bangor Hospital, Betsi Cadwaladr University Health Board	Bangor
United Kingdom	Furness General Hospital	Barrow In Furness
United Kingdom	Royal United Hospital Bath NHS Foundation Trust	Bath
United Kingdom	Birmingham Heartlands Hospital	Birmingham
United Kingdom	Queen Elizabeth Hospital Birmingham	Birmingham
United Kingdom	Royal Blackburn Hospital	Blackburn
United Kingdom	Blackpool Victoria Hospital	Blackpool
United Kingdom	Royal Bolton Hospital	Bolton
United Kingdom	Bristol royal Infirmary, University Hospitals Bristol	Bristol
United Kingdom	Southmead Hospital North Bristo; NHS Trust	Bristol
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	University Hospital of Wales (Cardiff)	Cardiff
United Kingdom	Broomfield Hospital	Chelmsford
United Kingdom	Countess of Chester	Chester
United Kingdom	Chesterfield Royal Hospital NHS Foundation Trust	Chesterfield
United Kingdom	University Hospitals Coventry and Warwickshire	Coventry
United Kingdom	Royal Devon & Exeter Hospital	Exeter
United Kingdom	Huddersfield Royal Infirmary	Huddersfield	West Yorkshire
United Kingdom	West Middlesex University Hospital (Isleworth)	Isleworth	Middlesex
United Kingdom	Victoria Hospital (Fife)	Kirkcaldy
United Kingdom	Royal Lancaster Infirmary	Lancaster
United Kingdom	Aintree Hospital	Liverpool
United Kingdom	Royal Liverpool and Broadgreen University Hospitals NHS Trust	Liverpool
United Kingdom	Royal Glamorgan Hospital	Llantrisant
United Kingdom	Macclesfield District General Hospital	Macclesfield
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	Wythenshawe Hospital	Manchester
United Kingdom	Queen Elizabeth The Queen Mother Hospital	Margate
United Kingdom	Newcastle Upon Tyne University Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Royal Gwent Hospital	Newport
United Kingdom	Norfolk and Norwich University Hospital	Norwich
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	John Radcliffe Hospital	Oxford	Oxfordshire
United Kingdom	Royal Alexandra Hospital	Paisley
United Kingdom	Plymouth Hospitals NHS Trust Derriford Hospital	Plymouth
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth
United Kingdom	Salford Royal Hospital	Salford	Greater Manchester
United Kingdom	Salisbury District Hospital	Salisbury	Wiltshire
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	Southampton General Hospital	Southampton
United Kingdom	Arrowe Park Hospital	Upton
United Kingdom	Pindersfields General Hospital	Wakefield	West Yorkshire
United Kingdom	Warrington Hospital	Warrington
United Kingdom	Warwick Hospital, South Warwickshire NHS Foundation Trust	Warwick
United Kingdom	Sandwell Hospital, SWBH NHS Trust	West Bromwich
United Kingdom	Royal Albert and Edward Infirmary	Wigan
United Kingdom	Mew Cross Hospital	Wolverhampton	West Midlands
United Kingdom	Wrexham Maelor Hospital, Betsi Cadwaladr University Health Board	Wrexham
United Kingdom	Yeovil District Hospital	Yeovil

Sponsors (5)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust	Liverpool Clinical Trials Unit, National Institute for Health Research, United Kingdom, Northwest Research Collaborative, University of Birmingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Pearce L, Newton K, Smith SR, Barrow P, Smith J, Hancock L, Kirwan CC, Hill J; North West Research Collaborative. Multicentre observational study of outcomes after drainage of acute perianal abscess. Br J Surg. 2016 Jul;103(8):1063-8. doi: 10.1002/bjs.10154. Epub 2016 Apr 7. — View Citation

Smith SR, Newton K, Smith JA, Dumville JC, Iheozor-Ejiofor Z, Pearce LE, Barrow PJ, Hancock L, Hill J. Internal dressings for healing perianal abscess cavities. Cochrane Database Syst Rev. 2016 Aug 26;(8):CD011193. doi: 10.1002/14651858.CD011193.pub2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound-related pain intensity	Wound-related pain intensity (worst pain during previous 24 hours) measured using a single 100mm Visual Analogue Scale where 0 represents 'no pain' and 100 represents 'worst pain possible'. The pain Visual Analogue Scale is a continuous scale comprised of a horizontal line 100mm in length, anchored by 2 verbal descriptors, one for each symptom extreme, where 0 represents 'no pain' and 100 represents 'worst pain possible'. The mean score over the first 10 post-operative days will be used.	Mean score over first 10 post-operative days
Secondary	Dressing-change related pain intensity	Pain before, during and after dressing change measured using a 100mm Visual Analogue Scale where 0 represents 'no pain' and 100 represents 'worst pain possible'. The pain Visual Analogue Scale is a continuous scale comprised of a horizontal line 100 mm in length, anchored by 2 verbal descriptors, one for each symptom extreme. The mean score for each timepoint (before, during and after) over the first 10 post-operative days will be used.	First 10 post-operative days
Secondary	Health related quality of life	Health related quality of life measured using EuroQol EQ-5D-5L quality of life questionnaires. The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.	On the 21st post-operative day
Secondary	Health utility	Health utility measured using EuroQol EQ-5D-5L quality of life questionnaires. The EQ-5D-5L descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension now has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The respondent is asked to indicate his/her health state by ticking (or placing a cross) in the box against the most appropriate statement in each of the 5 dimensions. This decision results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the respondent's health state.	On the 21st post-operative day
Secondary	Patient satisfaction with wound management	Patient satisfaction with wound management measured using a five point Likert scale. Patients are asked to mark the extent to which they agree with the statement 'I am satisfied with the way my wound has been treated following my surgery' where 1 equates to 'strongly disagree' and 5 equates to 'strongly agree'.	On the 21st post-operative day
Secondary	Rate of wound healing	Rate of wound healing (complete epithelialization)	Four and eight weeks post-operatively
Secondary	Clinical diagnosis of perianal abscesses recurrence after healing	Clinical diagnosis of perianal abscesses recurrence after healing, ascertained either through clinical follow-up as part of trial procedures or via central National Health Service registries.	52 weeks post-operatively
Secondary	Chronic post-surgical pain	Chronic post-surgical pain measured using the Brief Pain Inventory - Short Form. The Brief Pain Inventory - Short Form assesses the severity of pain and the impact on daily functions. Pain is assessed at its "worst," "least," "average," and "now" (current pain), measured on a scale of 1-10 where 1 represents "no pain" and 10 represents "pain as bad as you can imagine". The four items will be represented singly but a composite of the four pain items (a mean score) will be presented as supplemental information. Pain interference (impact of pain on seven daily activities) will be scored as the mean of the seven interference items. These items are scored between 1 and 10, where 1 represents "does not interfere" and 10 represents "completely interferes".	4, 8 and 26 weeks post-operatively
Secondary	Dressing use	Number of dressings used between time of operation up until week 52.	Up to 52 weeks post-operatively
Secondary	Health Professional contact time	Number of contacts with a Health Professional regarding perianal abscess or post-surgical complications between time of operation and 52 weeks post-operatively.	Up to 52 weeks post-operatively
Secondary	Hospital admission time	Number and length of hospital admissions as recorded in NHS central registries - Hospital Episodes Statistics.	Up to 52 weeks post-operatively
Secondary	Time to return to work or normal function	Length of time, measured in days, between operation and return to work or normal function.	Up to 52 weeks post-operatively
Secondary	Cost	Cost as applied to resource use data (see outcome 9-12)	Up to 52 weeks post-operatively
Secondary	Assessment of pain control methods	Assessment of pain control methods (i.e. pain control medications) using Patient Global Assessment of the method of pain control where a rating of the pain control method over the past 24 hours is rated as being one of "poor," "fair," "good," or "excellent".	21 days post-operatively
Secondary	Fistula rate	Fistula rate observed during clinical follow up and through Hospital Episodes Statistics	Up ro 52 weeks post-operatively